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24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease

18. januar 2018 opdateret af: GlaxoSmithKline

A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a 24-week, Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study. Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719/GW642444 62.5/25mcg, GW642444 25mcg, or tiotropium treatment groups in a 1:1:1:1 ratio. Treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI) and HandiHaler. There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 10 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 26 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods. At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/forced vital capacity (FVC) values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry. Spirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the morning and the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record peak expiratory flow (PEF) each morning, dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD. Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. General health status will be evaluated using the subject-completed EQ-5D questionnaire at Visits 2, 4, 6, and 8. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ) at Visits 2, 4, 6, and 8, and the subject-completed COPD Assessment Test (CAT) at Visits 2, 6, and 8. The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact. Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

846

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Chita, Den Russiske Føderation, 672000
        • GSK Investigational Site
      • Irkutsk, Den Russiske Føderation, 664005
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 115446
        • GSK Investigational Site
      • Petrozavodsk, Den Russiske Føderation, 185019
        • GSK Investigational Site
      • Ryazan, Den Russiske Føderation, 390039
        • GSK Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 194354
        • GSK Investigational Site
      • Saratov, Den Russiske Føderation, 410028
        • GSK Investigational Site
      • Saratov, Den Russiske Føderation, 410018
        • GSK Investigational Site
      • Tomsk, Den Russiske Føderation, 634001
        • GSK Investigational Site
      • Voronezh, Den Russiske Føderation, 394018
        • GSK Investigational Site
      • Yaroslavl, Den Russiske Føderation
        • GSK Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35216
        • GSK Investigational Site
    • California
      • San Diego, California, Forenede Stater, 92117
        • GSK Investigational Site
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • GSK Investigational Site
      • Orlando, Florida, Forenede Stater, 32822
        • GSK Investigational Site
      • Tampa, Florida, Forenede Stater, 33603
        • GSK Investigational Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • GSK Investigational Site
    • Missouri
      • Saint Charles, Missouri, Forenede Stater, 63301
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • GSK Investigational Site
    • Pennsylvania
      • Phoenixville, Pennsylvania, Forenede Stater, 19460
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406-7108
        • GSK Investigational Site
      • Gaffney, South Carolina, Forenede Stater, 29340
        • GSK Investigational Site
      • Greenville, South Carolina, Forenede Stater, 29615
        • GSK Investigational Site
      • Rock Hill, South Carolina, Forenede Stater, 29732
        • GSK Investigational Site
      • Seneca, South Carolina, Forenede Stater, 29678
        • GSK Investigational Site
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23229
        • GSK Investigational Site
  • Frankrig
      • Clermont Ferrand cedex 1, Frankrig, 63003
        • GSK Investigational Site
      • Nantes cedex 1, Frankrig, 44093
        • GSK Investigational Site
      • Nîmes cedex 09, Frankrig, 30029
        • GSK Investigational Site
      • Saint Pierre Cedex, Frankrig, 97448
        • GSK Investigational Site
  • Italien
    • Campania
      • Avellino, Campania, Italien, 83100
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Pordenone, Friuli-Venezia-Giulia, Italien, 33170
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italien, 00144
        • GSK Investigational Site
    • Liguria
      • Pietra Ligure (SV), Liguria, Italien, 17027
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italien, 20121
        • GSK Investigational Site
      • Pavia, Lombardia, Italien, 27100
        • GSK Investigational Site
      • Tradate (VA), Lombardia, Italien, 21049
        • GSK Investigational Site
    • Puglia
      • Foggia, Puglia, Italien, 71100
        • GSK Investigational Site
    • Sicilia
      • Catania, Sicilia, Italien, 95123
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italien, 56124
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 10700
        • GSK Investigational Site
      • Mexico City, Mexico, 07760
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • GSK Investigational Site
      • Zapopan, Jalisco, Mexico, 45200
        • GSK Investigational Site
  • Peru
      • Callao, Peru, Callao 2
        • GSK Investigational Site
      • Lima, Peru, Lima 1
        • GSK Investigational Site
    • Lima
      • Jesus Maria, Lima, Peru, Lima 11
        • GSK Investigational Site
      • Lima 27, Lima, Peru, Lima 27
        • GSK Investigational Site
      • San Borja, Lima, Peru, Lima 41
        • GSK Investigational Site
      • San Isidro, Lima, Peru, Lima 27
        • GSK Investigational Site
      • San Miguel, Lima, Peru, Lima 32
        • GSK Investigational Site
      • Santiago de Surco, Lima, Peru, Lima 33
        • GSK Investigational Site
  • Polen
      • Gdansk, Polen, 80-405
        • GSK Investigational Site
      • Gidle, Polen, 97-540
        • GSK Investigational Site
      • Krakow, Polen, 31-023
        • GSK Investigational Site
      • Lubliniec, Polen, 42-700
        • GSK Investigational Site
      • Sopot, Polen, 81-741
        • GSK Investigational Site
      • Wloclawek, Polen, 87-800
        • GSK Investigational Site
      • Zabrze, Polen, 41-800
        • GSK Investigational Site
  • Rumænien
      • Bacau, Rumænien, 600252
        • GSK Investigational Site
      • Bucharest, Rumænien, 011794
        • GSK Investigational Site
      • Ploiesti, Rumænien, 100184
        • GSK Investigational Site
      • Timisoara, Rumænien, 300310
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13086
        • GSK Investigational Site
      • Berlin, Tyskland, 10717
        • GSK Investigational Site
      • Berlin, Tyskland, 12203
        • GSK Investigational Site
      • Berlin, Tyskland, 12157
        • GSK Investigational Site
      • Hamburg, Tyskland, 22299
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Sinsheim, Baden-Wuerttemberg, Tyskland, 74889
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Tyskland, 70378
        • GSK Investigational Site
    • Bayern
      • Bamberg, Bayern, Tyskland, 96049
        • GSK Investigational Site
      • Erlangen, Bayern, Tyskland, 91052
        • GSK Investigational Site
      • Muenchen, Bayern, Tyskland, 80339
        • GSK Investigational Site
      • Nuernberg, Bayern, Tyskland, 90402
        • GSK Investigational Site
    • Brandenburg
      • Potsdam, Brandenburg, Tyskland, 14467
        • GSK Investigational Site
    • Hessen
      • Marburg, Hessen, Tyskland, 35037
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Tyskland, 30173
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Tyskland, 44263
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Tyskland, 44147
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49074
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49027
        • GSK Investigational Site
      • Donetsk, Ukraine, 83099
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61124
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61037
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 03038
        • GSK Investigational Site
      • Kyiv, Ukraine, 01114
        • GSK Investigational Site
      • Simferopol, Ukraine, 95043
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21029
        • GSK Investigational Site
      • Zaporizhia, Ukraine, 69035
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • outpatient
  • signed and dated written informed consent
  • 40 years of age or older
  • male and female subjects
  • COPD diagnosis
  • at least 10 pack-year smoking history
  • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
  • score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)

Exclusion Criteria:

  • women who are pregnant or lactating or are planning on becoming pregnant during the study
  • current diagnosis of asthma
  • other respiratory disorders other than COPD
  • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
  • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
  • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
  • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
  • lung volume reduction surgery within 12 months prior to Visit 1
  • abnormal and clinically significant ECG at Visit 1
  • significantly abnormal finding from laboratory tests at Visit 1
  • unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
  • use of depot corticosteroids within 12 weeks of Visit 1
  • use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
  • use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
  • use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
  • initiation or discontinuation of ICS within 30 days of Visit 1
  • use of tiotropium or roflumilast within 14 days of Visit 1
  • use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
  • short-acting oral beta-agonists within 12 hours of Visit 1
  • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
  • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
  • use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
  • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
  • long-term oxygen therapy prescribed for >12 hours per day
  • regular use of nebulized short-acting bronchodilators
  • participation in acute phase of pulmonary rehabilitation program
  • known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
  • anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
  • previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GSK573719/GW642444 125/25
125/25 mcg én gang dagligt
Medicin: GSK573719/GW642444 125/25
125/25 mcg én gang dagligt
Andre navne:
  • GSK573719/vilanteroltrifenatat
Eksperimentel: GSK573719/GW642444 62,5/25
62,5/25 mcg én gang dagligt
Medicin: GSK573719/GW642444 62.5/25
62.5/26 mcg once-daily
Andre navne:
  • GSK573719/vilanteroltrifenatat
Aktiv komparator: tiotropiumbromid
18 mcg én gang dagligt
Medicin: tiotropiumbromid
18 mcg én gang dagligt
Eksperimentel: GW642444
25 mcg once-daily
Medicin: GW642444
25 mcg once-daily
Andre navne:
  • vilanterol trifenatate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)
Tidsramme: Baseline and Day 169
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants. .
Baseline and Day 169

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline (BL) i vægtet gennemsnit (WM) 0-6 timers FEV1 opnået efter dosis på dag 168
Tidsramme: Baseline og dag 168
FEV1 er et mål for lungefunktionen og er defineret som den maksimale mængde luft, der kan udåndes kraftigt på et sekund. WM FEV1 blev udledt ved at beregne arealet under FEV1/tidskurven (AUC) ved hjælp af trapezreglen og derefter dividere værdien med det tidsinterval, som AUC blev beregnet over. WM blev beregnet på dag 1, 84 og dag 168 ved hjælp af 0-6 timers FEV1-målinger fra 0-6 timer opsamlet den dag, som inkluderede før-dosis (dag 1: 30 minutter [min] og 5 minutter før dosering andre serielle besøg: 23 og 24 timer efter den foregående morgendosis) og efter dosis efter 15 minutter, 30 minutter, 1 time, 3 timer og 6 timer. Ændring fra BL ved et bestemt besøg blev beregnet som WM ved det besøg minus BL. Analyse blev udført ved hjælp af en model med gentagne målinger med kovariater af behandling, BL (gennemsnit af de to vurderinger foretaget 30 minutter og 5 minutter før dosis på dag 1), rygestatus, centergruppe, dag og dag for BL og dag for behandling interaktioner.
Baseline og dag 168

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline (BL) i gennemsnitlig åndenød med daglige aktiviteter (SOBDA)-score for uge 24
Tidsramme: Baseline og uge 24
Det nyudviklede SOBDA-spørgeskema vurderer dyspnø eller åndenød (SOB) med daglige aktiviteter. SOBDA-spørgeskemaet består af 13 punkter udfyldt af deltageren (par.) hver aften før sengetid, når par. pålægges at reflektere over den aktuelle dags aktiviteter. Den daglige score beregnes som gennemsnittet af scorerne på de 13 punkter (>=7 punkter skal have ikke-manglende svar for at dette kan beregnes). Par. tildeles en ugentlig gennemsnitlig SOBDA-score, der spænder fra 1 til 4 (større score indikerer mere alvorlig åndenød ved daglige aktiviteter) baseret på gennemsnittet af 7 dages data (>=4 af 7 dage skal fuldføres for at et ugentligt gennemsnit kan beregnes) . Ændring fra BL er den gennemsnitlige ugentlige SOBDA-score minus BL. Analyse blev udført ved hjælp af MMRM med kovariater af behandling, BL (gennemsnitlig score i ugen før behandling), rygestatus, centergruppe, uge, uge ​​for BL og uge efter behandlingsinteraktioner. Denne MMRM-analyse inkluderede kun uge 4, 8, 12 og 24.
Baseline og uge 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

24. april 2012

Datoer for studieregistrering

Først indsendt

15. marts 2011

Først indsendt, der opfyldte QC-kriterier

15. marts 2011

Først opslået (Skøn)

16. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 113360

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Statistisk analyseplan
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk undersøgelsesrapport
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasætspecifikation
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annoteret sagsbetænkningsformular
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokol
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formular til informeret samtykke
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individuelt deltagerdatasæt
    Informations-id: 113360
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GSK573719/GW642444 125/25

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